A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    Bellerophon Pulse Technologies
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Updated on 16 February 2024
See if I qualify
ct scan
treatment regimen
x-rays
pneumonia
nitric oxide
covid-19
chest x-ray
SARS
oxygen supplementation
acute respiratory syndrome (sars)

Summary

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.

Description

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed iNO compared to placebo in subjects with COVID-19 who are hospitalized and require supplemental oxygen without assisted ventilation. Subjects will be randomized to receive placebo or iNO125 mcg/kg ideal body weight (IBW)/hour 24 hours daily up to 14 days or until resolution or discharge.

Details
Condition Coronavirus Infection, Coronavirus, Covid 19
Age 18years - 100years
Treatment Placebo, INOpulse
Clinical Study IdentifierNCT04421508
SponsorBellerophon Pulse Technologies
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed informed consent
At least 18 years old
Symptoms of shortness of breath within previous 8 days prior to screening
Subjects must have
proven or high suspicion of SARS-CoV-2 infection and
O2 saturation < 92% on room air, and
require supplemental O2 10 L/minute, and
radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)
Female subjects must have a negative pregnancy test
Willing and able to comply with the treatment schedule and study procedures

Exclusion Criteria

Participating in another clinical trial of an investigational treatment for COVID-19
Methemoglobin > 3%
Evidence of severe multi organ failure
Use of assisted ventilation prior to initiation of iNO
Pregnancy or positive pregnancy test pre-dose
Open tracheostomy
Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening
History or clinical evidence of heart failure, left ventricular dysfunction (LVEF <40%)
Subjects reporting hemoptysis
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